olaparib
olaparib: sourced relationships with 1 company · 81 clinical trials tracked · 2 FDA decisions.
olaparib evidence translation
What we can confirm
2 FDA records · 81 tracked trials
What it means
What to watch
Prepared research question
How could olaparib → AZN affect its developer, and what evidence supports the link?
Traceable citations · Unknowns marked
See linked entities and source evidence8 indications · 6 study sponsors
Related indications
Dated Pipeline Records (1)
| Company | Dated record stage |
|---|---|
| ASTRAZENECA PLC (AZN) Reported 2014-12-19 · Current development: unknownSource Metastatic Castration-resistant Prostate Cancer; Breast Canc… | Phase 4 |
Clinical Trial Registry Records (81)showing 10 most recent
Non-Interventional, Observational, Retrospective and Prospective, Single- Arm Study to Assess the Effectiveness of Olaparib and Abiraterone Combination as First Line Therapy in NHA Pre-exposed mCRPC Patients in the GCC Region
Primary endpoint: Evaluate the time to treatment discontinuation (TTD) or death (event-free rate) at 6 and 12 months in 1L NHA pre-exposed mCRPC patients treated with Olaparib + Abiraterone.
A Phase 1b Dose Escalation and Expansion Study of IMGN151 as Monotherapy and in Combination With Other Anti-Cancer Therapies in Subjects With Gynecologic Cancers
Primary endpoint: Number of Participants With Dose-limiting Toxicities (DLTs)
A Randomized Phase 3 Trial Evaluating the Safety & Efficacy of IP IMNN-001 Administered in Combination w/ Standard Neoadjuvant & Adjuvant Chemotherapy in Newly Diagnosed Patients w/ Advanced EOC, Fallopian Tube or Primary Peritoneal Cancer
Primary endpoint: Overall Survival
A Phase 3, Randomized, Open-label Study to Evaluate the Efficacy and Safety of Sac-TMT (Sacituzumab Tirumotecan, MK-2870) Followed by Carboplatin/Paclitaxel vs Chemotherapy, Both in Combination With Pembrolizumab as Neoadjuvant Therapy for High-Risk, Early-Stage, Triple-Negative Breast Cancer or Hormone Receptor-low Positive/Human Epidermal Growth Factor Receptor-2 Negative Breast Cancer
Primary endpoint: Percentage of Participants with Pathological Complete Response (pCR) at the Time of Definitive Surgery
A Phase 2, Umbrella Study to Evaluate the Safety, Tolerability, and Clinical Activity of Investigational Agents for Newly Diagnosed, High-Risk, Early-Stage Triple-Negative Breast Cancer
Primary endpoint: Number of participants with one or more adverse events (AEs)
An Open-label Randomized Phase 2 Study to Evaluate Safety and Efficacy of Patritumab Deruxtecan Plus Pembrolizumab Administered Either Before or After Carboplatin/Paclitaxel Plus Pembrolizumab Compared With Pembrolizumab in Combination With Chemotherapy Followed by Surgery and Adjuvant Pembrolizumab for High-Risk Early-Stage Triple-Negative or Hormone Receptor-Low Positive/Human Epidermal Growth Factor Receptor-2 Negative Breast Cancer (HERTHENA-Breast03)
Primary endpoint: Part 1: Number of Participants Experiencing an Adverse Event (AE)
A Phase III Trial of One vs. Two Years of Maintenance Olaparib, With or Without Bevacizumab, in Patients With BRCA1/2 Mutated or Homologous Recombination Deficient (HRD+) Ovarian Cancer Following Response to First Line Platinum-Based Chemotherapy
Primary endpoint: Progression free survival (PFS) at least 360 days after randomization (PFS360)
A Phase 2, Open-label, Multi-centre Study of FPI-2265 (225Ac-PSMA-I&T) and Olaparib in Participants With Metastatic Castration Resistant Prostate Cancer (mCRPC)
Primary endpoint: Evaluate anti-tumour activity of FPI-2265 administered in combination with olaparib
A Phase II Study Combining Pembrolizumab With Olaparib in Metastatic Pancreatic Adenocarcinoma (PDA) Patients With Mismatch Repair Deficiency or Tumour Mutation Burden > 4 Mutations/Mb
Primary endpoint: Objective Response Rate (ORR)
Phase Ib Study of Axatilimab in Combination With Olaparib in BRCA1/2 and PALB2- Associated Metastatic HER2-negative Breast Cancer
Primary endpoint: Maximum Tolerated Dose (MTD)
FDA Decisions2 records
Frequently asked questions
Which companies have sourced relationships with olaparib?
olaparib has dated SEC/FDA relationship records for ASTRAZENECA PLC.
How many clinical trials involve olaparib?
BioSniper tracks 81 clinical trials involving olaparib.
What is olaparib's latest FDA decision?
The most recent tracked FDA decision for olaparib is Approval for 1 INDICATIONS AND USAGE Lynparza is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated: Ovarian cancer • for the maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA -mutated advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy. Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza. ( 1.1 , 2.1 ) • in c, dated August 17, 2017.